EUnetHTA Training course for Stakeholders - Brief introduction to EUnetHTA and its Tools (Finn BORLUM KRISTENSEN

EUnetHTA
European network for
Health Technology Assessment

Brief introduction to EUnetHTA and its Tools
WP2, Centre Pacheco, Brussels, January 16, 2014

Finn Børlum Kristensen, MD, PhD
Adjunct professor, University of Southern Denmark
Director, EUnetHTA Secretariat
Danish Health and Medicines Authority (EUnetHTA Coordinator),
Copenhagen, Denmark
European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu

Participants in EUnetHTA
EUnetHTA Partners and
Associates in JA2.

44 Partner organisations
designated by Member States
Large number of regional
agencies and non-for-profit
organisations that produce
or contribute to HTA


2

What is Health Technology Assessment?
• Health technology assessment (HTA) is a multidisciplinary process that

summarises information about the medical, social, economic and ethical
issues related to the use of a health technology, in a systematic, transparent,
unbiased, robust manner.

• Its aim is to inform the formulation of safe, effective, health policies that are
patient focused and seek to achieve best value.

• Despite its policy goals, HTA must always be firmly rooted in research and
the scientific method.


3

Challenges in advancing HTA and the path
toward a robust and efficient network
•

Standardising where appropriate and quality assuring scientific and
technical methodologies in HTA

•

Harmonising approaches in HTA and relative effectiveness assessment
(REA) across multiple jurisdictions

•

Encouraging transparent open dialogue on medicinal assessment
methods to improve decision-making in drug development

•

Increasing collaboration between HTA authorities, industry, patient
organisations - and payers to ensure fair pricing and reimbursement


4

Scope of EUnetHTA’s work


5

Scope of EUnetHTA’s work
EUnetHTA supports collaboration between European
HTA organisations that brings added value at the
European, national and regional level through
- facilitating efficient use of resources available for HTA

- creating a sustainable system of HTA knowledge sharing
- promoting good practice in HTA methods and processes.


6

European initiatives in HTA to harmonise
evidence requirements
• Early scientific advice to technology sponsors
• Additional data collection
• Guidelines on assessing outcomes
• Aligning HTA and regulatory needs
• Involving stakeholders in a shared process


7

Article 15 of the Directive 2011/24/EU
on cross-border health care
“The Union shall support and facilitate cooperation
and the exchange of scientific information among Member States
within a voluntary network connecting national authorities or bodies

responsible for health technology assessment designated by the
Member States… That network shall be based on the principle
of good governance including transparency, objectivity,
independence of expertise, fairness of procedure

and appropriate stakeholder consultations”


8

The timeline of reaching a sustainable
and permanent HTA network in Europe
Health
Programme

2014-2020

2005

2011

Call for joint
action

Call for
joint
action

2006-2008

2009

2010-2012

2012-2015

2016-2020

EUnetHTA
Project

Legislation

2009

Call for
project
proposals

EUnetHTA
Collaboration

EUnetHTA
JA

EUnetHTA
JA2

EUnetHTA
Scientific and
technical cooperation

Financial support
HTA

2008-2011

2011-12

2013

2013+

Draft Cross Border
Healthcare Directive.
Article 15 on HTA network

CBHC Directive
now decided

EU
Cooperation
on HTA
Implementing
Decision

HTA Network

DG R&I

2011 FP7-Health

Horizon 2020

2012-Innovation-1

Calls

New methodologies for HTA

Health Care


9

Project

Establishment

JA1

Putting into
practice


JA2

Strengthening
practical
application

10

The pharmaceutical Forum suggested that EUnetHTA
could be a relevant candidate for taking forward the
scientific recommendations on Relative Effectiveness
Assessment of Pharmaceuticals (2008)
Health
Programme

2014-2020

2005

2009

2011

Call for
project
proposals

Call for joint
action

Call for
joint
action

2006-2008

2009

2010-2012

2012-2015

2016-2020

EUnetHTA
Project

EUnetHTA
Collaboration

EUnetHTA
JA

EUnetHTA
JA2

EUnetHTA
Scientific and
technical cooperation

Financial support
HTA

Include REA
of drugs

Some: All technologies

HTA institutions
Some: Not drugs
Drugs evaluation institutions
(several MEDEV members),
now also called HTA


The Domains of the
HTA Core Model®
SCOPE

HTA Core Model DOMAINS

3. Safety

Full

4. Clinical effectiveness
5. Costs and economic evaluation
6. Ethical analysis
7. Organisational aspects
8. Social aspects
9. Legal aspects

Value ???

2. Description and technical characteristics

Reliable, timely, transparent,
transferable HTA information

Rapid

1. Health problem and current use of technology

EUnetHTA output


13

Use of technology in health care

Health Technology
Life-cycle
HTA / REA

Early scientific
advice

Rapid
REA

Additional
data
collection

Time line of innovation


14


15

The POP Database
Description

Purpose

The EUnetHTA Planned and Ongoing Projects
(POP) database allows EUnetHTA Partners
and Associates to share information on
planned, ongoing or recently published projects
of participating agencies and identify similar
projects through a matching system provided
by the online database.

To facilitate
collaboration among
European HTA
agencies and reduce
duplication of work.


16

The POP Database
Online

Access to the POP Database : http://eunethta.dimdi.de/PopDB/


17

The EVIDENT
Database
Description

Purpose

The EVIDENT Database enables sharing early
information on evidence gaps identified during
the production of HTA reports and consequent
recommendations / requests for additional data
collection.

To reduce redundancy,
promote generation
of further evidence
and facilitate European
collaboration in the
domain.

It also contains information on reimbursement/
coverage and assessment status of promising
technologies in Europe.


18

The EVIDENT Database
Online

Access to the EVIDENT Database: https://evident.has-sante.fr/has/login.xhtml


19

9 Methodological Guidelines
for Rapid REA
Development
9 Methodological Guidelines for Rapid
REA of Pharmaceuticals developed in
JA1 by WP5.
Content
Guidelines on methodological
challenges that are encountered by
health technology assessors while
performing a rapid relative effectiveness assessment of pharmaceuticals.
Primary Aim
To help the assessors of evidence
interpret and process the data that are
presented to them as part of a REA


20

EUnetHTA output and
national HTA work


21

Core HTA Structure
Primarily EUnetHTA

Pool of structured
HTA Information

Primarily national

Local products

Collections
Serve also as project platforms

L HTA

INFORMATION

Official EUnetHTA

L RHTA

Core HTA
L HTA

RC
RC

RC

RC

RC

RC

RC

RC

Rapid HTA
AUTOMATIC

L RHTA

VOLUNTARY

Other

L RHTA

RC

RC

RC

RC

RC

Full domain

RC

RC

RC

RC

RC

Free set (≥ 1)
L HTA

TOOLS

My collection

L HTA

TAILORED

HTA Core Model
Online Tool & Service

Local Tools
Primarily EUnetHTA


Primarily local

22

Submission template of evidence requirements from
HTA organisations that reflects the HTA Core Model

Collection and analysis of current national evidence
requirements +
HTA Model structure
Pilot version to be field tested in Rapid REA


23

EUnetHTA Joint Action 2 (2012-2015)
Objectives
- To strengthen the practical application of tools
and approaches to cross-border HTA collaboration
- To achieve a better understanding for the European Commission
and Member States of ways to establish a sustainable structure
for HTA work in the EU

- To produce recommendations regarding the design and
management of the future EU HTA cooperation

Total budget: € 9,428,550


24

- To strengthen the practical application of tools
and approaches to cross-border HTA collaboration

• At least 28 pilot exercises
• Joint assessments applying full or rapid HTA Core Model
• Early dialogues, methodological guidelines, submission template
• Trainings in tools and approaches ( provided to staff of HTA agencies
and to stakeholders (patients and providers)
• At least 40 national HTA reports with the use of tools and information from
Joint Action 2

• External co-operation
• R&I FP 7 research projects
• EU JAs (PARENT JA)
• EMA – EUnetHTA co-operation

25

Stakeholder
involvement


26

Composition of the EUnetHTA
Stakeholder Forum

Payers

Patients/
Consumers

Industry


Providers

27

Purpose of the
Stakeholder Forum
To provide stakeholders with
the opportunity
- to participate as stakeholder
representatives in the EUnetHTA
Joint Actions
- to observe and comment on the
EUnetHTA Joint Action work
- to provide advice to overarching
governance questions in the Joint
Actions, and
- to bring forward specific themes and
concerns considered relevant by the
stakeholders' constituencies and in
line with the aims of the EUnetHTA
Joint Actions


28

Purpose of the Stakeholder
Advisory Groups (SAGs)
Representatives from Stakeholder
organisations participate in WP
activities via SAGs to
- represent Stakeholder views
- provide perspectives and knowledge on
the EUnetHTA work in progress
- Help WPs to improve the basis of their
deliberations
- Examples of participation:
- Commenting on the scope of the
project / selected methodologies
- Commenting on draft reports in
preparation of final draft documents
before public consultation


29

External
Collaboration


30

Thank you for your
attention
This presentation arises from the EUnetHTA
Joint Action 2 which has received funding
from the European Union, in the framework
of the Health Programme


HTA 2.0 Europe


EUnetHTA Training course for Stakeholders - Brief introduction to EUnetHTA and its Tools (Finn BORLUM KRISTENSEN

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